Trial Outcomes & Findings for Nesiritide and Renal Function After the Total Artificial Heart (NCT NCT01836809)
NCT ID: NCT01836809
Last Updated: 2016-02-08
Results Overview
TERMINATED
PHASE4
2 participants
46 hours
2016-02-08
Participant Flow
Participant milestones
| Measure |
Total Artificial Heart
Active arm of Total Artificial Heart group
randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus
|
Total Artificial Heart: Placebo
This arm included subject who received a total artificial heart and will be randomized receive placebo
|
LVAD: Nesiritide
Active arm of the LVAD group
randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus
|
LVAD: Placebo
This arm will consist of subjects who received an LVAD and will be randomized to placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nesiritide and Renal Function After the Total Artificial Heart
Baseline characteristics by cohort
| Measure |
Total Artificial Heart
Active arm of the Total Artificial Heart group
randomized to nesiritide
|
Total Artificial Heart: Placebo
Total Artificial Heart group
randomized to placebo
|
LVAD: Nesiritide
Active arm of the LVAD group
randomized to nesiritide
|
LVAD: Placebo
n=2 Participants
Control arm of the LVAD group
randomized to placebo
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
—
|
—
|
59.5 years
n=4 Participants
|
59.5 years
n=21 Participants
|
|
Age, Categorical
<=18 years
|
—
|
—
|
—
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
—
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
—
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Gender
Female
|
—
|
—
|
—
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Gender
Male
|
—
|
—
|
—
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
—
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 46 hoursPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 46 HoursPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 90 daysPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 46 HoursPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 46 HoursPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 46 HoursPopulation: Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm
Outcome measures
Outcome data not reported
Adverse Events
Total Artificial Heart
Total Artificial Heart: Placebo
LVAD: Nesiritide
LVAD: Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place